FDA Drug recall D-1428-2016
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, S…
- FDA Drug
- Class II
- terminated
- Published 2016-07-27
On 2016-07-27 the FDA classified a Class II recall of 5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, S… by Pharmedium Services, citing presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1428-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-05 |
| Published | 2016-07-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
5 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8483, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-483-61
Reason
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Identifiers
| code_info | Lot Number 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Ex…Lot Number 160380152M , Exp. Date 5/8/2016 ; Lot Number 160400233M , Exp. Date 5/10/2016 ; Lot Number 160540186M , Exp. Date 5/24/2016 ; Lot Number 160660046M , Exp. Date 6/4/2016 ; Lot Number 160730154M , Exp. Date 6/12/2016 ; Lot Number 160750176M , Exp. Date 6/14/2016 ; Lot Number 160760046M , Exp. Date 6/14/2016 ; Lot Number 160800066M , Exp. Date 6/18/2016 ; Lot Number 160820111M , Exp. Date 6/20/2016 ; Lot Number 160960039M , Exp. Date 7/4/2016 ; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1428-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.